Kornimate/medical-research-clean huggingface dataset:
effects of multi-direction stepping and weight shifting exercises in stroke patients

Conditions: Stroke

Summary: stoke is a leading cause of disability that results not only in persistent neurological deficits but also profound physical de-conditioning that propagates stroke-related secondary disability. several kinds of research have reported that there has been asymmetrical weight bearing on the affected side while sitting and standing resulting in impaired performance especially reaching in sitting, rising from the chair, walking, and climbing stairs. despite the stroke patient being able to walk independently with or without the walking aids, the patient still lacks the normal movement pattern especially weight transfers on the affected side while performing such activities which subsequently decreases the patient to restrain the challenges while walking, decrease confidence in functional activities. also, further, there hasn't been enough literature on this topic. therefore, the objective of this study is to find out the effectiveness of multidirectional stepping and weight shifting exercises to improve dynamic balance and gait speed in stroke patients.

the twenty-four subjects who fulfilled the inclusion criteria were selected for the study and were randomly assigned into two groups of 12 subjects each by simple random sampling based on inclusion criteria. first, all the subjects were assessed with a detailed neurological assessment form after the consent form was taken from the patients. the experimental group was given multidirectional stepping exercise with conventional therapy whereas are control group was given only conventional therapy.

Eligibility criteria:
inclusion criteria: * diagnosed with stroke via ct scan or mri * maintain the independent standing posture for 30 sec * ability to walk 3 meters independently without an assistive device * mini-mental status examination score \>21 points * could communicate and understand therapist's verbal command * voluntary agreed to participate in the study * age above 18 years old * medically stable (e.g. recent myocardial infarction, unstable angina, ventricular tachycardia) exclusion criteria: * visual disorders and visual deficits * history of any neurological pathology like parkinson's or alzheimer's disease * conditions affecting balance like vertigo * medications affecting balance * dementia * impaired conscious level or concomitant medical illness * lower motor neuron lesions * anti-spasmodic medication (e.g. baclofen, dantrolene sodium, etc.) * severe orthopedic diseases in lower extremities (e.g. osteoarthritis, fracture, sprain, strain)

Keywords: stroke balance gait berg balance scale functional gait assessment
impact of prevention awareness group (pag) on treatment attendance and drug abstinence among substance user

Conditions: Substance Use Disorder; Drug Dependence,; Alcohol Dependence

Summary: substance use disorder has been showing a rising trend all over the world including india. the project tested whether a integrated community wide effort of prevention and awareness groups (pag) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.


Eligibility criteria:
inclusion criteria: * suburban, rural population * drug and/or alcohol dependency (dsm-iv substance use disorders criteria) exclusion criteria: * did not consent to participate * planning to move or relocate * severe mental disorder

Keywords: prevention and awareness groups (pag), substance use disorder, community based intervention
a single time-point study to evaluate the conformis itotal (ps) knee replacement system versus off-the-shelf

Conditions: Osteoarthritis, Knee

Summary: this study is designed to compare outcome data for patients who have recently undergone surgery with the itotal® posterior stabilizing (ps) knee replacement system (hereafter referred to as the "itotal") versus those who have undergone surgery with off-the-shelf (ots) systems.

this is a prospective, single-time point study that will be conducted in the us.to compare outcomes of these two study groups, this study will include routine office questionnaires such as the knee society score (kss) and the knee injury and osteoarthritis outcome score (koos).the functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. the testing is designed to closely mimic daily activities with which the subjects are familiar.

Eligibility criteria:
inclusion criteria: * implant must be a minimum of 6 months post-op and doing well in the opinion of site staff * subject has had a knee replacement utilizing a fixed bearing ps (posterior stabilized) implant design * \> 18 years of age * willingness to participate in the clinical study, to give informed consent, and to perform all evaluations exclusion criteria: * simultaneous or staged bilateral procedure * bmi \> 40 * other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function * participation in another clinical study which would confound results * inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Keywords: osteoarthritis osteoarthritis knee total knee replacement patient specific total knee arthroplasty orthopedics
post-market follow up study of the 'bpk-s integration' uc as primary implant in the variants cocr or ceramic

Conditions: Osteoarthritis; Osteoarthritis, Knee; Joint Instability; Arthritis; Joint Disease; Musculoskeletal Disease; Rheumatic Diseases

Summary: prospective post-market clinical follow up study according to meddev 2.12/2 rev2 of the european union. patients receiving the primary knee implant bpk-s uc as primary implant in either variant ceramic or cocr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation). patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.


Eligibility criteria:
inclusion criteria: * congenital or acquired knee joint defects/deformation * defects or malfunction of the knee joint * arthrosis (degenerative, rheumatic) * post-traumatic arthritis * symptomatic knee instability * reconstruction of flexibility * patients with metal hypersensitivity (ceramic tibia/femur) exclusion criteria: * illnesses which can be treated without using a knee joint implant. * acute or chronic infections near the implantation * systemic diseases and metabolic disorders * serious osteoporosis * serious damage to the bone structures that impedes stable implantation of the implant components * diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc. * bone tumors in the area of the implant anchoring * obesity or overweight of the patient * overload of the knee implant to be expected * abuse of medication, drug abuse, alcoholism or mental disease * pregnancy * lack of patient cooperation * sensitivity to foreign matter in the implant materials * patients under the age of 18 * patients participating in another trial
mechanisms of muscle blood flow dysregulation and exercise intolerance in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: patients with chronic kidney disease (ckd) experience fatigue and exercise intolerance. increased oxidative stress in ckd may be a contributing factor. the role of impaired muscle blood flow regulation has not been fully explored. the investigators hypothesize that functional sympatholysis is exaggerated in ckd and this is associated with increased oxidative stress. the investigators also hypothesize that exercise training will improve functional sympatholysis and oxidative stress

progressive muscle weakness and premature fatigue are characterize the condition of chronic kidney disease (ckd) which can be very debilitating. mechanisms underlying exercise intolerance in ckd is not completely understood. previous studies have demonstrated impaired skeletal muscle vasodilation during exercise in ckd patients, which may contribute to exercise intolerance. normally, there is blunting of sympathetic mediated vasoconstriction in exercising muscle to allow for steady blood supply to exercising muscles. this phenomenon is called functional sympatholysis. functional sympatholysis is impaired by increases in reactive oxygen specie and may be impaired in ckd. experiments will be performed on 2 groups of subjects 1) normal kidney function (egfr\>90) 2) stage 2-3 ckd (egfr 30-89). vasoactive medications will be held for 72 hours before study. all participants will attend a baseline study visit, which will include a physical examination, a medical history review, vital sign measurements, and blood collection. muscle nerve activity and muscle oxygenation will be measured while the subjects perform hand grip exercise at 30% maximum voluntary contraction with and without lower body negative pressure (- 20 mmhg). muscle blood flow will be measured before and after hand grip exercises. ckd subjects will then be randomized to exercise training (to squeeze a tennis ball repeatedly for at least 30 min/day) or no exercise training for 28 days. procedures in baseline visit will be repeated followed by cross over to alternate group for 28 days followed by repeat of baseline procedures. blood flow, muscle oxygenation and muscle nerve activity will be compared between ckd and normal subjects as well as before and after exercise training for ckd subjects.

Eligibility criteria:
inclusion criteria: * normotensive adults * ckd 2-3 exclusion criteria: * blood pressure ≥140/90 * egfr \>60ml/min/1.73 m2 or egfr \<30ml/min/1.73 m2 * any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography. * diabetes mellitus or other systemic illness * pregnancy * any history of substance abuse or current cigarette use * any history of psychiatric illness * history of malignancy

Keywords: chronic kidney disease functional sympatholysis exercise training exercise intolerance handgrip exercise near infrared spectroscopy lower body negative pressure
a real world study of mobocertinib in adults with lung cancer in china (meaning)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - egfr exon 20 insertion mutation) during normal clinical practice. participants will be treated with mobocertinib as per their normal routine. data for this study will be collected from the available medical records of a participant.

this is a non-interventional, prospective, observational study of participants with egfr ex20ins positive locally advanced or metastatic non-small cell lung cancer (nsclc) who received mobocertinib in china's routine clinical practice setting. the primary objective of this study is to assess the real-world time-to-treatment discontinuation (rwttd) of mobocertinib in study participants. the study will enroll approximately 120 participants. participants will be enrolled in the following cohort: • mobocertinib participants will be treated with mobocertinib as per their normal routine treatment. data for this study will be collected from the available medical records of a participant every 3 months until the end of treatment and follow up (up to 18 months). this multi-center trial will be conducted in china. the overall duration of the study will be approximately 3 years.

Eligibility criteria:
inclusion criteria: 1. participants with histologically/cytologically confirmed diagnosis of egfr ex20ins positive locally advanced or metastatic nsclc by local hospitals. 2. participants who received mobocertinib as treatment therapy in routine clinical practice; the decision to treat with mobocertinib had to be made independently by physician before enrollment into the study. 3. the decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study. exclusion criteria: 1. participants who are participating in other nsclc interventional clinical study during the treatment of mobocertinib in this study will be excluded; 2. other situations that the investigators consider not suitable for participation in this study.

Keywords: drug therapy
treatment to promote self-regulation in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Self-Regulation, Emotion

Summary: this study will evaluate the feasibility of repetitive transcranial magnetic stimulation (rtms) in autism spectrum disorder (asd) with self-regulation impairment. baseline and follow-up participant visits will include behavioral assessments of self-regulation and magnetic resonance imaging (mri) to determine neurophysiological outcomes before and after rtms treatment.

children and youth with autism spectrum disorder (asd) often present with co-morbid impairments in self-regulation (e.g., difficulty managing their emotions) resulting in unhelpful regulatory approaches such as disruptive compulsive, aggressive and self-injurious behaviour. there is an urgent need to establish novel, precise and effective interventions that promote self-regulation and reduce disruptive behaviours. this project will collect pilot data on the effects of repetitive tms in reducing disruptive behaviours in youth with asd, in order to inform the design of a follow-up full-scale clinical trial. youth with asd who experience clinically significant difficulties with self-regulation and disruptive behaviour will be recruited. participants will be randomized to rtms or sham rtms for 3 weeks. the overall feasibility of the trial will be assessed. the effect of rtms on the brain mechanisms of self-regulation and clinical improvement in disruptive behaviours will also be measured. neurophysiological outcomes, including changes in regional brain network activity for inhibition of behaviour, will be explored.

Eligibility criteria:
inclusion criteria: * children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges * able to participate in rtms exclusion criteria: * children with autism spectrum disorder but no co-morbid self-regulation disorders. * children with contraindications to tms (history of seizures, family history of seizures, metal implants) * co-existing neurological conditions (epilepsy, stroke, etc.)

Keywords: transcranial magnetic stimulation rtms mri
the genetic basis for vulnerability to substance abuse

Conditions: Substance Abuse

Summary: this investigation seeks to better define the genetic basis for vulnerability to substance abuse.

dopamine (da), a neurotransmitter helping to mediate reward and reinforcement, has been putatively linked to the development of substance abuse, alcohol abuse, and alcoholism. identification of specific vulnerability-association alleles for receptors, other molecules within the reward mediating system, and other genes that may predispose individuals to the development of such disorders is the goal of the study. this investigation will help elucidate the genetic underpinnings of substance abuse, potentially leading to the improved methods to diagnose those at risk and to help develop better therapeutic interventions.

Eligibility criteria:
inclusion criteria: * substance abusers * allow for blood draw exclusion criteria: * cognitively impaired

Keywords: substance abuse
prognostic markers of acute heart failure with chronic kidney disease

Conditions: Chronic Kidney Diseases; Acute Heart Failure; Biomarker

Summary: acute heart failure (ahf) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. n-terminal pro-brain natriuretic peptide (nt-pro-bnp) is one of the most developed prognostic markers for ahr patients and. nt-pro-bnp has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (ckd). plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without ckd hospitalized for ahf.


Eligibility criteria:
inclusion criteria: * hospitalized for acute heart failure exclusion criteria: * initial serum nt-probnp level \<300ng/ml, pregnancy, amputated, and end-stage renal disease under regular dialysis
active surveillance for cancer of the prostate (ascap)

Conditions: Prostate Cancer

Summary: active surveillance (a.s.) of prostate cancer (cap) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. a.s. is different from watchful waiting (w.w.), which is the palliative treatment of men with progressive prostate cancer.

this protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. longitudinally, specimens and clinical data will be collected to provide information on the following: * imaging studies of the prostate * rates of curative intervention * measures of tumor recurrence/progression * disease specific survival * overall survival * clinical data to track quality of life

Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate. 2. clinically localized prostate cancer: t1-2, nx or n0, mx or m0. 3. no previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). 4. patient has elected active surveillance as preferred management plan for prostate cancer. 5. patient consent has been obtained according to local institutional review board . 6. patient is accessible and compliant for follow-up. exclusion criteria: 1. unwillingness or inability to undergo serial prostate biopsy. 2. overall life expectancy less than 2 years 3. advanced prostate cancer

Keywords: prostate cancer low risk gleason 6 active surveillance
observational study of glucose tolerance abnormalities in patient with cystic fibrosis homozygous for phe 508 del cftr treated by lumacaftor-ivacaftor

Conditions: Cystic Fibrosis Homozygous for Phe 508 Del CFTR; Glucose Intolerance or Newly Diagnosis Diabetes

Summary: cystic fibrosis related diabetes (cfrd), a major factor of morbid-mortality in cf, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years. at the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in cf. indeed insulin secretion is dependent of the cftr activity at the beta cell surface and inhibition of cftr leads to a decrease in insulin secretion. recently, the combination of the lumacaftor, a cftr corrector, with ivacaftor, a cftr potentiator, was studied in patient with cf homozygous for the phe508 del cftr mutation patients and showed an improvement of the respiratory state in comparison with the placebo group. these data suggests that lumacaftor in combination with ivacaftor in targeting cftr action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.


Eligibility criteria:
inclusion criteria: * patients with cf homozygous for the phe508del cftr mutation aged 12 years and over * combined lumacaftor-ivacaftor treatment scheduled or already started * glucose intolerance in ogtt (ada criteria) or newly diabetes diagnosed at the ogtt (ada criteria) or diabetic patients with insulin requirement ≤ 0.3 unit / kg / day or without insulin treatment * signed informed consent of patient and of one parent or legal representative for minor subject exclusion criteria: * hypersensitivity to the active substances or to any of the excipients of lumactfor -ivacaftor * lung and/or liver transplant patient * known diabetes with insulin treatment \> 0.3 unit / kg / day * patient pregnant or wishing to pregnancy

Keywords: cystic fibrosis glucose tolerance abnormalities cftr corrector and potentiator
efficacy of ciclesonide and fluticasone propionate in adult patients with moderate and severe persistent asthma (18 to 75 y) (by9010/it-101)

Conditions: Asthma

Summary: the aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. the study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). the study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria:
main inclusion criteria: * written informed consent * history of bronchial asthma for at least 6 months * pre-treatment with cfc-beclomethasone dipropionate (cfc-bdp) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (laba) either in free or fixed combination * fev1 ≥ 80% of predicted main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of labas * copd * smoking with ≥10 pack-years * pregnancy * intention to become pregnant during the course of the study * breast feeding * lack of safe contraception

Keywords: asthma ciclesonide fluticasone propionate
thresholds in food allergy evaluation and prediction

Conditions: Tree Nut Allergy; Food Allergy

Summary: thresholds in food allergy evaluation and prediction, a prospective, observational registry. the aim is to quantify food allergy thresholds in canada and their clinical predictors.


Eligibility criteria:
inclusion criteria: 1. suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific ige. a suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food. 2. ability to discontinue all antihistamines for 1 week before oral food challenge. exclusion criteria: 1. previous desensitization treatment to a food allergen 2. allergies to any component of the oral challenge vehicle 3. unstable conditions including uncontrolled asthma or chronic urticaria 4. any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Keywords: immunotherapy food allergy diagnosis prognosis